This one-day course is designed for those who need to better understand what medical device audit is, what it is trying to do, how to do it, and when it is required.
You might be new to medical devices, about to get involved with internal audit, perhaps you are thinking of becoming an auditor? Perhaps you are a senior manager who wants to know the fundamentals to help you manage your team?
In just one day, the course will cover:
– Role of the key players in Europe: Competent Authorities and Notified Bodies.
– Where to find key guidance so you can answer the exam question!
– Standards you can learn from.
– What is the ‘Blue Guide’ and why it is so important.
– Notified Body Unannounced Audits and the effect on the supply chain.
– Differences between Competent Authority and Notified Body Audits.
– MDR/IVDR and ISO 13485: 2016 and effect on audits.
– Insights about United States (US) Food and Drug Administration (FDA) Inspections.
– Comments on the Medical Device Single Audit Program (MDSAP) and why this matters so much to those who want to market to Canada!
– The Direction of Travel!
– What is CE marking and why the ‘Blue Guide’ matters.
– Auditing – the process for effective results.
To view the programme and further information (including target audience, learning outcomes and speaker profile) click on the Event Brochure link below.
Member cost: £ 200
Non-Member cost: £ 300
All prices are excluding VAT
Once we receive your booking form, you will be sent a confirmation email and an invoice.
How to find iGEM House:
The venue is located in Kegworth, 3 minutes from junction 24 of the M1 and 3.4 miles from East Midlands Parkway Train Station. There is free parking available for delegates. For a map and further instructions, please click here.